Director, Clinical Research Operations

Posted about 1 month agoViewed

United StatesFull-TimeClinical Research

Company:Care Access

Location:United States

Languages:English

Seniority level:Director, 12+ years

Experience:12+ years

Skills:

LeadershipProject ManagementGCPPeople ManagementCross-functional Team LeadershipOperations ManagementResource PlanningCommunication SkillsMentoringComplianceQuality AssuranceTrainingBudgetingRisk ManagementProcess improvement

Requirements:

Strong knowledge of ICH-GCP, FDA regulations, and clinical trial execution.
Excellent leadership, communication, and performance-management skills.
Ability to thrive in dynamic environments and manage diverse clinical teams.
Bachelor’s degree in a health-related field required; advanced degree preferred.
12+ years of clinical research operations experience, including leadership of multisite or dispersed clinical teams.
Experience overseeing CRCs, nurses, mobile clinicians, or traveling clinical staff.

Responsibilities:

Lead clinical operations across physical sites, mobile units, and traveling clinical teams.
Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations.
Oversee clinical workflows at sites and mobile deployments.
Manage, develop, and evaluate all clinical research staff.
Implement training, competency standards, and performance expectations for all clinical staff.
Provide input into staffing budgets, resource planning, and clinical support models.
Monitor enrollment, data quality, documentation practices, and clinical performance metrics.
Partner with regulatory, medical, data, participant experience, and site operations teams.
Drive continuous improvement in clinical quality, consistency, and operational efficiency.